Drugplain

ACETAMINOPHEN PM 500 mg/1

Acetaminophen 500mg / Diphenhydramine HCl 25mg · TABLET, FILM COATED · Ulai Health LLC

1 Recall on RecordCurrently in Shortage
Plain English

Acetaminophen PM is an over-the-counter pain reliever and sleep aid that combines acetaminophen to reduce pain and fever with diphenhydramine to help you fall asleep. It comes as an oral tablet and is used for temporary relief of minor aches, pains, and headaches while helping promote sleep.

Key Facts

Brand Name
ACETAMINOPHEN PM
Generic Name
Acetaminophen 500mg / Diphenhydramine HCl 25mg
NDC Code (Product)
73057-352
Manufacturer
Ulai Health LLC
Strength
500 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M013
Marketing Start
07/08/2019

Recall History

1 Recall on Record
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use22,398 reports
fatigue20,468 reports
drug ineffective18,174 reports
pain18,128 reports
nausea17,638 reports
headache16,726 reports
toxicity to various agents15,677 reports
dyspnoea14,583 reports
arthralgia14,320 reports
pyrexia14,280 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Dosage & Administration

Directions Do not take more than directed. See overdose warning adults and children 12 years and over take 2 caplets at bedtime do not take more than 2 caplets of this product in 24 hours children under 12 years do not use

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

Frequently Asked Questions

What is ACETAMINOPHEN PM used for?

Acetaminophen PM is an over-the-counter pain reliever and sleep aid that combines acetaminophen to reduce pain and fever with diphenhydramine to help you fall asleep. It comes as an oral tablet and is used for temporary relief of minor aches, pains, and headaches while helping promote sleep.

Is ACETAMINOPHEN PM a controlled substance?

ACETAMINOPHEN PM is not classified as a controlled substance by the DEA.

What is the generic name for ACETAMINOPHEN PM?

The generic name for ACETAMINOPHEN PM is Acetaminophen 500mg / Diphenhydramine HCl 25mg. There are no other listed brand versions of Acetaminophen 500mg / Diphenhydramine HCl 25mg.

What is the NDC code for ACETAMINOPHEN PM 500 mg/1?

The NDC (National Drug Code) for ACETAMINOPHEN PM 500 mg/1 is 73057-352, listed by Ulai Health LLC.

Product NDC

73057-352

Package NDC

73057-352-03

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)